In a major setback, Israel-based
Pluristem Therapeutics Inc.
) recently announced that it has received notification from the
US Food and Drug Administration (FDA), placing a clinical hold on
the phase II intermittent claudication (IC) study (IND
The FDA's decision was based on a serious allergic reaction in
one of the patients which required subsequent
The patient was discharged the next day after the symptoms
Pluristem pointed out that the patient was suffering from
multiple diseases which may have affected the severity of the
However, the FDA will issue a letter to Pluristem within the
next 30 days asking for further information.
Pluristem currently does not have any approved
product/therapy. Hence, the clinical hold on the mid-stage trial
significantly disappointed investors. The news led to a 14.4%
decline in the stock price on Jun 4, 2013.
We expect investor focus in the near term to remain on further
updates on the clinical hold.
We note that Pluristem develops placenta-based cell therapies
in collaboration with companies like
) or through research and clinical institutions.
The cells from placenta are derived using the company's
proprietary PluriX therapy and are known as PLacental eXpanded
(PLX) cells. Pluristem's first candidate in development, PLX-PAD,
is intended to treat peripheral artery disease (PAD).
Meanwhile, the company is also evaluating PLX-PAD for the
treatment of critical limb ischemia and Buerger's disease.
Celgene Cellular Therapeutics, a wholly-owned subsidiary of
), is also conducting research on stem cells derived from the
human placenta as well as from the umbilical cord for the
treatment of different diseases.
ANIKA THERAPEUT (ANIK): Free Stock Analysis
CELGENE CORP (CELG): Free Stock Analysis
PLURISTEM THERA (PSTI): Free Stock Analysis
UTD THERAPEUTIC (UTHR): Free Stock Analysis
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Pluristem carries a Zacks Rank #4 (Sell). Right now,
Anika Therapeutics, Inc.
) looks attractive with a Zacks Rank #1 (Strong Buy).